A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation (NCT06218238) | Clinical Trial Compass
RecruitingNot Applicable
A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation
United States20 participantsStarted 2024-04-01
Plain-language summary
Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unilateral, transfemoral amputation (any etiology).
* Age from 45-75 years.
* Residual limb length classified as standard (i.e., medium) to long.
* Prosthesis user for at least 1 year prior to enrolling in the study.
* K3 or K4 level ambulator.
* Good sensation on their residual limb(s) (upon routine clinical examination).
* Good skin integrity upon visual inspection.
* Does not require the use of assistive devices to walk for short distances.
* Not currently taking medications that are known to affect balance or gait.
* Presents with good socket fit based upon a standard assessment by the study prosthetist.
Exclusion Criteria:
* Bilateral amputations
* Individuals with a knee disarticulation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Walking speed
Timeframe: To be measured after the 1-month accommodation period of wearing each prosthetic knee component
2
Metabolic energy cost
Timeframe: To be measured after the 1-month accommodation period of wearing each prosthetic knee component
3
Sit-to-stand/stand-to-sit symmetry
Timeframe: To be measured after the 1-month accommodation period of wearing each prosthetic knee component